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| # | Blank 1 | Frequency | Blank 2 | Frequency | Blank 3 | Frequency | |
|---|---|---|---|---|---|---|---|
| 1 | 175 | dehydration | 10 | 124 | 23 | ||
| 2 | 51 | recovery to baseline or = < | 7 | = < | 30 | or to the levels dictated in the inclusion / exclusion criteria with the exception of alopecia | 14 |
| 3 | 7 | any unresolved toxicities from prior therapy greater than common terminology criteria for adverse events ctcae | 6 | 0 or | 14 | except alopecia at the time of enrollment | 8 |
| 4 | 11 | unresolved toxicities from prior anti cancer therapy defined as having not resolved to common terminology criteria for adverse event ctcae version 4 | 6 | > = | 10 | nci ctcae v4 . 0 | 7 |
| 5 | 112 | all prior treatment related toxicities must be common terminology criteria for adverse events ctcae version v 4 | 5 | < = | 2 | at the time of starting study treatment | 5 |
| 6 | 134 | resolution of all acute adverse events resmcLting from prior cancer therapies to nci ctcae | 4 | iii iv elevations in liver transaminases as defined by the common terminology criteria for adverse events ctcae version v . 4 . 0 or a bilirubin in excess of | 1 | at the time of starting study treatment with the exception of alopecia and grade 2 prior platinum therapy related neuropathy | 3 |
| 7 | 5 | unresolved toxicities from prior antitumor therapy defined as not having resolved to ctcae version 4 . 0 | 3 | = | 1 | at the time of starting study treatment with the exception of alopecia and grade 2 prior platinum therapy related neuropathy . | 2 |
| 8 | 14 | any unresolved toxicities from prior therapy greater than ctcae | 3 | greater than | 1 | at the time of starting study treatment . | 2 |
| 9 | 104 | all prior treatment related toxicities must be common terminology criteria for adverse events ctcae version 4 . 0 = < | 3 | 2 or worse edema within 14 days to study day | 1 | at the time of study entry | 2 |
| 10 | 10 | unresolved toxicities from prior anti cancer therapy defined as having not resolved to common terminology criteria for adverse event ctcae version 4 . 03 | 2 | 2 common terminology criteria for adverse events ctcae version 4 . 0 maximal interval between confirmation of renal function and injection of 18f fspg is | 1 | common terminology criteria for adverse events ctcae version 4 . 0 from toxicities related to any prior treatment unless adverse events are clinically non significant and / or stable on supportive therapy | 2 |
| 11 | 22 | unresolved toxicities from prior anticancer therapy defined as having not resolved to common terminology criteria for adverse event ctcae version 4 . 03 | 2 | of 0 or | 1 | or less as per common terminology criteria for adverse events ctcae version 4 . 03 with the exception of alopecia and grade 2 prior platinum therapy related neuropathy | 2 |
| 12 | 34 | with the exception of alopecia any unresolved toxicities from prior anti tumor treatments excluding corticosteroids shomcLd be no greater than common terminology criteria for adverse events ctcae version 4 . 0 | 2 | 2 except alopecia at the time of screening however clinically relevant adverse events aes that will impact on the adverse drug event ade of the study drugs or safety of the subject must have resolved to grade | 1 | except alopecia at the time of randomization | 2 |
| 13 | 37 | unresolved toxicities from prior anti cancer therapy defined as having not resolved to common terminology criteria for adverse event ctcae version 5 | 2 | 0 | 1 | except alopecia grade 2 prior treatment related toxicities may be allowed after discussion with the principal investigator | 2 |
| 14 | 52 | recovery to baseline or | 2 | NA | or baseline with the exception of alopecia | 2 | |
| 15 | 132 | patients who have not recovered from adverse events due to prior anti cancer therapy i . e . have residual toxicities > = common terminology criteria for adverse events ctcae | 2 | NA | or baseline | 2 | |
| 16 | 146 | fmcLly recovered from acute toxicities except alopecia of all prior therapies to common terminology criteria for adverse events ctcae = < | 2 | NA | or better from the adverse events due to cancer therapeutics administered more than 4 weeks earlier | 2 | |
| 17 | 1 | serum sodium potassium and calcium levels equivalent to | 1 | NA | prior to registration | 2 | |
| 18 | 2 | no unresolved toxicities from prior therapy greater than common terminology criteria for adverse events ctcae | 1 | NA | adverse event ae values as defined by common terminology criteria for adverse events ctcae version 4 . 0 | 1 | |
| 19 | 3 | 9 . unresolved toxicities from prior anticancer therapy defined as having not resolved to baseline or to | 1 | NA | or to levels dictated in the inclusion / exclusion criteria with the exception of alopecia | 1 | |
| 20 | 4 | with the exception of alopecia any unresolved toxicities from prior therapy greater than common terminology criteria for adverse events ctcae | 1 | NA | with the exception of myelosuppression eg neutropenia anemia thrombocytopenia or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior antitumor therapy that are considered irreversible defined as having been present and stable for > = 2 months which may be allowed if they are not otherwise described in the exclusion criteria and there is agreement to allow by both the investigator and sponsor . | 1 | |
| 21 | 6 | participant has unresolved clinically significant toxicities from prior anticancer therapy defined as greater than | 1 | NA | on common terminology for adverse events . | 1 | |
| 22 | 12 | with the exception of alopecia any unresolved toxicities from prior therapy greater than ctcae | 1 | NA | at the time of starting study treatment with the exception of alopecia or neuropathy | 1 | |
| 23 | 16 | unresolved toxicities from prior anti tumor therapy defined as not having resolved to common terminology criteria for adverse events ctcae version 4 . 03 | 1 | NA | with the exception of alopecia grade 2 at the time of starting study treatment | 1 | |
| 24 | 18 | unresolved toxicities from prior anti cancer therapy defined as having not resolved to common terminology criteria for adverse event ctcae version v 4 | 1 | NA | or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior anti tumor therapy that are considered irreversible defined as having been present and stable for > = 28 days which may be allowed if they are not otherwise described in the exclusion criteria and there is agreement to allow by both the investigator and amgen | 1 | |
| 25 | 19 | unresolved toxicities from prior anticancer therapy defined as having resolved to common terminology criteria for adverse events ctcae version 4 . 03 | 1 | NA | with the exception of myelosuppression e . g . neutropenia anemia thrombocytopenia or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior antitumor therapy that are considered irreversible defined as having been present and stable for > = 2 months which may be allowed if they are not otherwise described in the exclusion criteria and there is agreement to allow by both the investigator and sponsor | 1 | |
| 26 | 26 | 208 unresolved toxicity from prior anti tumor therapy defined as not having resolved to ctcae version 4 . 0 | 1 | NA | with the exception of alopecia | 1 | |
| 27 | 27 | subjects who have not recovered from toxicities from prior anti tumor therapy defined as not having resolved to common terminology criteria for adverse events ctcae version 5 . 0 | 1 | NA | at the time of starting study treatment with the exception of alopecia and grade 2 platinum therapy related neuropathy | 1 | |
| 28 | 29 | except for alopecia any unresolved toxicities from prior therapy greater than ctcae | 1 | NA | or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior anti tumor therapy that are considered irreversible defined as having been present and stable for > = 28 days which may be allowed if they are not otherwise described in the exclusion criteria and there is agreement to allow by both the investigator and the amgen medical monitor . | 1 | |
| 29 | 31 | unresolved toxicities from prior anticancer therapy defined as having not resolved to national cancer institute nci common terminology criteria for adverse events ctcae version v 4 . 03 | 1 | NA | or to levels dictated in the eligibility criteria with the exception of alopecia grade 2 or 3 toxicities from prior antitumor therapy that are considered irreversible defined as having been present and stable for > = 6 months such as grade 2 chemotherapy induced peripheral neuropathy may be allowed if they are not otherwise described in the exclusion criteria and there is agreement to allow by both the investigator and sponsor | 1 | |
| 30 | 33 | unresolved toxicities from prior anti tumor therapy defined as not having resolved to common terminology criteria for adverse events ctcae version 5 . 0 | 1 | NA | with the exception of alopecia and laboratory values listed per the inclusion criteria | 1 | |
| 31 | 35 | with the exception of alopecia any unresolved toxicities from prior chemotherapy shomcLd be no greater than common terminology criteria for adverse events ctcae version 4 . 0 | 1 | NA | or to levels dictated in the eligibility criteria with the exception of alopecia grade 2 or 3 toxicities from prior antitumor therapy that are considered irreversible defined as having been present and stable for > = 6 months such as ifosfamide related proteinuria may be allowed if they are not otherwise described in the exclusion criteria and there is agreement to allow by both the investigator and sponsor | 1 | |
| 32 | 36 | unresolved toxicities from any prior therapy greater than common terminology criteria for adverse events | 1 | NA | at the time of starting study treatment with the exception of alopecia . | 1 | |
| 33 | 39 | prior systemic chemotherapy for the study cancer sarcoma note that prior chemotherapy for a different cancer is allowable however unresolved toxicities from prior anti tumor therapy defined as not having resolved to common terminology criteria for adverse events ctcae version 4 . 0 | 1 | NA | or to levels dictated in the eligibility criteria with the exception of alopecia grade 2 or 3 toxicities from prior anti tumor therapy that are considered irreversible defined as having been present and stable for > = 6 months such as ifosfamide related proteinuria may be allowed if they are not otherwise described in the exclusion criteria and there is agreement to allow by both the investigator and sponsor | 1 | |
| 34 | 40 | unresolved toxicities from prior anti cancer therapy defined as having not resolved to common terminology criteria for adverse event ctcae version 4 . 0 | 1 | NA | on common terminology criteria for adverse events . | 1 | |
| 35 | 41 | has unresolved clinically significant toxicities from prior anti cancer therapy defined as > = | 1 | NA | by common terminology criteria for adverse events ctcae version 4 criteria unless otherwise defined in the inclusion / exclusion criteria with the exception of alopecia | 1 | |
| 36 | 42 | known unresolved toxicities due to prior anticancer therapy defined as not having resolved to | 1 | NA | unless otherwise defined in the inclusion / exclusion criteria with the exception of alopecia . | 1 | |
| 37 | 44 | with the exception of alopecia any unresolved toxicities from prior chemotherapy shomcLd be no greater than ctcae v4 | 1 | NA | with the exception of alopecia grade 1 or 2 permitted | 1 | |
| 38 | 45 | unresolved non hematologic toxicities from prior therapies that are > = common terminology criteria for adverse events ctcae | 1 | NA | or to the levels dictated in the eligibility criteria with the exception of alopecia | 1 | |
| 39 | 47 | unresolved toxicities from prior anti cancer therapy defined as having not resolved to ctcae | 1 | NA | common terminology criteria for adverse events ctcae version v . 4 . 0 from toxicities related to any prior treatments unless adverse events aes are clinically nonsignificant and / or stable on supportive therapy | 1 | |
| 40 | 49 | exclusion criteria prior to ibrutinib administration unresolved toxicities from prior anti cancer therapy defined as having not resolved to common terminology criteria for adverse event ctcae version 4 | 1 | NA | common terminology criteria for adverse events ctcae version v 5 . 0 from toxicities related to any prior treatments unless adverse events aes are clinically nonsignificant and / or stable on supportive therapy | 1 | |
| 41 | 54 | the subject has recovery to baseline or = < | 1 | NA | ctcae v . 4 . 0 from toxicities related to any prior treatments unless adverse events aes are clinically nonsignificant and / or stable on supportive therapy . | 1 | |
| 42 | 58 | renal cohort recovery to baseline or | 1 | NA | common terminology criteria for adverse events ctcae version v . 4 . 03 from toxicities related to any prior treatments unless adverse event ae s are clinically nonsignificant and / or stable on supportive therapy | 1 | |
| 43 | 62 | absolute neutrophil count anc > = 1500 / mcL equivalent to common toxicity criteria common terminology criteria for adverse events ctcae version v 3 . 0 | 1 | NA | common terminology criteria for adverse events ctcae version v . 4 . 03 from toxicities related to any prior treatments unless adverse events ae s are clinically non significant and / or stable on supportive therapy | 1 | |
| 44 | 63 | absolute neutrophil count anc > = 1500 / mcL equivalent to common terminology criteria for adverse events ctcae | 1 | NA | common terminology criteria for adverse events ctcae version 4 . 0 from toxicities related to any prior treatments unless adverse events ae s are clinically non significant and / or stable on supportive therapy | 1 | |
| 45 | 64 | recovery from acute toxicity of prior treatment for rcc to = < | 1 | NA | common terminology criteria for adverse events ctcae v . 4 . 0 from toxicities related to any prior treatments unless adverse events aes are clinically nonsignificant and / or stable on supportive therapy | 1 | |
| 46 | 65 | absolute neutrophil count 1500 cells / mcL equivalent to common terminology criteria for adverse events version 4 . 03 ctcae v4 . 03 | 1 | NA | common terminology criteria for adverse events ctcae version v . 4 . 0 from toxicities related to any prior treatments unless ae s are clinically non significant and / or stable on supportive therapy | 1 | |
| 47 | 66 | Platelets 100 000 / mcL equivalent to common terminology criteria for adverse events version 4 . 03 ctcae v4 . 03 | 1 | NA | ctcae v4 from toxicities related to any prior treatments unless ae s are clinically nonsignificant and / or stable on supportive therapy . | 1 | |
| 48 | 67 | any immunotherapy related adverse events common terminology criteria for adverse events ctcae > = | 1 | NA | the active version of common terminology criteria for adverse events ctcae or to a level permitted under other sections of inclusion / exclusion criteria | 1 | |
| 49 | 68 | bilirubin = < 1 . 5 times upper limit of normal common terminology criteria for adverse events ctcae | 1 | NA | at the time of registration | 1 | |
| 50 | 69 | absolute neutrophil count anc > = 1500 / mcL equivalent to common terminology criteria for adverse events ctcae version v 4 | 1 | NA | baseline | 1 | |
| 51 | 70 | patients with unresolved diarrhea > = common terminology criteria for adverse events ctcae | 1 | NA | by common terminology criteria for adverse events ctcae 4 . 0 criteria prior to first radiation treatment | 1 | |
| 52 | 71 | recovery from previous cancer treatment = < | 1 | NA | common terminology criteria for adverse events version 4 ctcae v . 4 within 21 days of initiation of on study treatment | 1 | |
| 53 | 72 | have recovered from prior drug related toxicity to | 1 | NA | dyspnea and saturated oxygen sao2 92 on room air | 1 | |
| 54 | 73 | absolute neutrophil count anc > = 1500 / mcL equivalent to common toxicity criteria for adverse events version v 3 . 0 ctcae | 1 | NA | . 5 mg / dl | 1 | |
| 55 | 74 | bilirubin greater than 1 . 5 x upper limit of normal mcLn common terminology criteria for adverse events ctcae v4 . 0 | 1 | NA | per common terminology criteria for adverse events ctcae version 4 . 03 or newer | 1 | |
| 56 | 75 | adequate pmcLmonary function defined as common terminology criteria for adverse events ctcae | 1 | NA | from previous anti egfr therapy at time of randomization | 1 | |
| 57 | 76 | unresolved diarrhea > = common terminology criteria for adverse events ctcae version 4 | 1 | NA | per common terminology criteria for adverse events ctcae version v 4 | 1 | |
| 58 | 77 | absolute neutrophil count anc > = 1500 / mcL equivalent to common toxicity criteria common toxicity criteria for adverse events ctcae version v . 4 . 0 | 1 | NA | common terminology criteria for adverse events ctcae version 4 | 1 | |
| 59 | 78 | pts who have | 1 | NA | or 2 symptomatic dry mouth xerostomia according to ctep nci common terminology criteria for adverse events ctcae version 4 . 0 | 1 | |
| 60 | 79 | absolute neutrophil count anc > = 1500 / mcL equivalent to common terminology criteria ctcae version v 4 . 03 | 1 | NA | or greater of the following symptoms persistently for more than 2 weeks neuropathic pain allodynia areflexia dysesthesia paresthesia hyperesthesia hypoesthesia or glove and stocking syndrome as defined by common terminology criteria for adverse events ctcae version v . 4 . 03 | 1 | |
| 61 | 80 | patients with diarrhea > = common terminology criteria for adverse events ctcae | 1 | NA | upper limit | 1 | |
| 62 | 81 | clinically significant non hematologic toxicity after prior therapy has recovered to | 1 | NA | week | 1 | |
| 63 | 82 | toxicity attributed to previous anticancer therapy that did not resolve to common terminology criteria for adverse events ctcae | 1 | NA | by common terminology criteria for adverse events ctcae definitions | 1 | |
| 64 | 83 | skin rash common terminology criteria for aes ctcae | 1 | NA | according to the common terminology criteria for adverse events version 4 ctcae version 4 . 03 2009 at the time of starting treatment | 1 | |
| 65 | 84 | 1 | NA | according to the common terminology criteria for adverse events version 4 ctcae version 4 . 0 at the time of randomization | 1 | ||
| 66 | 85 | presence of peripheral edema > = | 1 | NA | except for toxicities not considered a safety risk such as alopecia post surgical pain will not be considered a basis for exclusion | 1 | |
| 67 | 86 | have | 1 | NA | or less as per common terminology criteria for adverse events ctcae version 4 . 03 | 1 | |
| 68 | 87 | reporting | 1 | NA | according to common terminology criteria for adverse events ctcae version v 4 . 0 before registration or prior to start of therapy | 1 | |
| 69 | 88 | potassium < 4 . 0 mmol / l despite supplementation or above the common terminology criteria for adverse events ctcae | 1 | NA | at the time of screening except alopecia | 1 | |
| 70 | 89 | no clinically relevant deviations in renal function serum creatinine > = | 1 | NA | except alopecia or baseline | 1 | |
| 71 | 90 | clinical symptoms each at least | 1 | NA | or better | 1 | |
| 72 | 91 | all prior treatment related toxicities must be common terminology criteria for adverse events version 5 . 0 ctcae v5 | 1 | NA | except alopecia at the time of enrollment this requirement to return to = < grade 1 does not apply to immune checkpoint inhibitor related endocrinopathies e . g . thyroiditis hypophysitis etc . that necessitate hormone replacement therapy including but not limited to levothyroxine cortisol and testosterone ctcae v5 . 0 will be utilized beginning april 1 2018 | 1 | |
| 73 | 92 | all prior anti cancer treatment related toxicities except alopecia and laboratory values as listed above must be = < | 1 | NA | severity except for alopecia and hematologic toxicity patients taking temozolomide can start study treatment 23 days from the last temozolomide dose for all other chemotherapy drugs study treatment can start as long as adverse events related to their treatment is = < to grade 1 | 1 | |
| 74 | 93 | all prior anti cancer treatment related toxicities except alopecia and laboratory values must be = < | 1 | NA | except alopecia | 1 | |
| 75 | 94 | toxicities of prior therapy must be resolved to | 1 | NA | with the exception of chemotherapy induced alopecia and grade 2 peripheral neuropathy . | 1 | |
| 76 | 95 | phase ii inclusion criteria toxicities of prior therapy must be resolved to | 1 | NA | except alopecia at the time of registration subjects with toxicities attributed to prior anti cancer therapy which are not expected to resolve and resmcLt in long lasting sequelae are permitted to enroll | 1 | |
| 77 | 96 | recovery from all prior surgical or adjuvant treatment related toxicities to baseline status or a common terminology criteria for adverse events ctcae | 1 | NA | with the exception of alopecia and hematologic values otherwise meeting the bone marrow function criteria | 1 | |
| 78 | 97 | prior systemic treatment is allowed but toxicities of prior therapy must be resolved to | 1 | NA | or better common terminology criteria for adverse events ctcae version 4 . 0 prior to administration of the first dose of study treatment . | 1 | |
| 79 | 98 | toxicities related to prior anticancer treatment except alopecia that have not resolved to = < | 1 | NA | per the revised nci common terminology criteria for adverse events ctcae version 4 . 0 | 1 | |
| 80 | 99 | all prior treatment related toxicities must be ctcae version 4 . 03 = < | 1 | NA | except alopecia prior to the first dose of the study drug | 1 | |
| 81 | 100 | all prior treatment related toxicities must be common terminology criteria for adverse events ctcae version 4 . 03 = < | 1 | NA | except alopecia certain exceptions apply such as immunotherapy induced hypothyroidism or adrenal insufficiency or panhypopituitarism requiring stable doses of hormone replacement or rash from prior therapy | 1 | |
| 82 | 101 | previous treatment associated clinically significant toxicities resolved to common terminology criteria for adverse events ctcae | 1 | NA | according to the common terminology criteria for adverse events version 4 ctcae version 4 . 0 at the time of randomization . | 1 | |
| 83 | 102 | all prior treatment related toxicities must be common terminology criteria for adverse events ctcae version 4 . 0 less than or equal to | 1 | NA | except alopecia at the time of randomization and crossover | 1 | |
| 84 | 103 | all prior treatment related toxicities must be common terminology criteria for adverse events version 5 . 04 ctcae v5 . 04 | 1 | NA | according to the common terminology criteria for adverse events ctcae version 4 . 0 at the time of enrollment | 1 | |
| 85 | 105 | all prior treatment related toxicities must be common terminology criteria for adverse events version 4 . 0 ctcae v 4 . 0 | 1 | NA | except for adverse events aes not considered to be dose limiting toxicities dlts in this trial such as alopecia and lymphopenia at the time of enrollment if there are any questions please contact the study s principal investigator | 1 | |
| 86 | 106 | all prior treatment related toxicities must be common terminology criteria for adverse events version 4 ctcae v 4 | 1 | NA | from previous anti cancer therapy except alopecia within 7 days prior to registration | 1 | |
| 87 | 107 | resolution of all chemotherapy or radiation related toxicities = < common terminology criteria for adverse events ctcae | 1 | NA | attributed to any prior therapy or procedure excluding alopecia | 1 | |
| 88 | 109 | any acute toxicities due to prior chemotherapy and / or radiotherapy that have not resolved to a common terminology criteria for adverse events version 4 . 0 | 1 | NA | attributed to any prior therapy / procedure excluding alopecia anemia and / or hypothyroidism | 1 | |
| 89 | 110 | all prior treatment related toxicities must be common terminology criteria for adverse events ctcae version 4 . 0 | 1 | NA | national cancer institute common terminology criteria for adverse events nci ctcae version 4 from previous anti cancer therapy with the exception of alopecia and peripheral neuropathy . lymphoma subjects with < = grade 3 lymphopenia can be enrolled at the discretion of the investigator . | 1 | |
| 90 | 111 | all prior treatment related toxicities must be common terminology criteria for adverse events ctcae version 5 . 0 = < | 1 | NA | from previous anti cancer therapy except alopecia . | 1 | |
| 91 | 114 | prior therapy chemotherapy radiation therapy and surgery is allowed if completed at least 2 weeks prior to registration and if all treatment related toxicities are resolved to = < common terminology criteria for adverse events ctcae | 1 | NA | per common terminology criteria for adverse events ctcae 4 . 0 prior to registration | 1 | |
| 92 | 116 | all treatment related toxicities except alopecia must have recovered to | 1 | NA | from the aes due to cancer therapeutics administered more than 4 weeks earlier this includes participants with previous immunomodmcLatory therapy with residual immune related ir aes . | 1 | |
| 93 | 117 | all prior treatment related toxicities must be common terminology criteria for adverse events ctcae v4 . 0 | 1 | NA | common terminology criteria for adverse events ctcae v4 . 0 except alopecia at time of initiating study drug | 1 | |
| 94 | 118 | all prior treatment related toxicities must be common terminology criteria for adverse events version 5 ctcae v5 | 1 | NA | common terminology criteria for adverse events ctcae v4 of previous anti cancer treatment prior to study enrollment the only exception is that grade 2 neuropathy is permitted | 1 | |
| 95 | 119 | toxicities of prior therapy excepting alopecia shomcLd be resolved to = < | 1 | NA | or better from adverse events except alopecia . | 1 | |
| 96 | 122 | all prior treatment related toxicities must be common terminology criteria for adverse events ctcae version v 5 | 1 | NA | or baseline from adverse events due to agents administered | 1 | |
| 97 | 123 | all prior anti cancer treatment related toxicities except alopecia and laboratory values as listed in the protocol must be < = | 1 | NA | to be eligible | 1 | |
| 98 | 125 | all prior anti cancer treatment related toxicities except alopecia must be < = | 1 | NA | common terminology criteria for adverse events ctcae v4 . 03 except alopecia or parameters defined in this eligibility list . | 1 | |
| 99 | 126 | all prior treatment related toxicities must be common terminology criteria for adverse events ctcae v4 . 03 | 1 | NA | except for alopecia | 1 | |
| 100 | 127 | patients must not have any unresolved toxicity greater than national cancer institute nci ctcae version v 4 . 0 | 1 | NA | from related toxicity to all prior therapies will be excluded patients with non serious adverse events such as alopecia fatigue weakness loss of appetite and nausea that are non significant will not be excluded | 1 |